BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211855 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09891
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/13/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD IS PEELING AT THE OK BUTTON. THE OK & DOWN BUTTONS HAVE AN INTERMITTENT RESPONSE. THE UP BUTTON IS COMPLETELY UNRESPONSIVE. THE CONTRAST BUTTON RESPONDS PROPERLY. THERE WAS CONTAMINATION UNDER ALL OF THE BUTTON CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING TACTILE CHANGES ON THE PUMP PRIOR TO DAMAGE. THE REPORTER STATED THAT FOR APPROXIMATELY ONE MONTH PRIOR TO THE COMPLAINT, THE BUTTONS BECAME VERY DIFFICULT TO PRESS. IN ADDITION, PEELING OF THE KEYPAD WAS OBSERVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311704 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR